Clinical research, which encompasses the vast area of pharmaceutical research, is one of the cornerstones of the biomedical translation market in Spanish-speaking countries. Clinical trials sponsored by multinational pharmaceutical companies or large medical device manufacturers generate enormous volumes of documentation each year that need to be translated from English into Spanish. Examples or these are study protocols; investigator brochures; expert reports and other regulatory documents; informed consent forms and supporting documents or case report forms. 

The translators responsible for producing these texts in Spanish need to have not only a good knowledge of English, but also a grasp of medicine, pharmacy, epidemiology, statistics, biochemistry and mathematics, and, in particular, a thorough understanding of the wider context surrounding clinical research as a component of the drug development process. 

The Diccionario inglés-español de investigación clínica (DIC) is intended as a practical tool to help specialised translators working in the complex field of clinical research.

DIC is an extension of the online EN-SP clinical trials glossary Glosario EN-ES de ensayos clínicos (GEC) that I published as lead author in Panace@, Revista de Medicina, Lenguaje y Traducción, along with the following colleagues:

- Fernando A. Navarro
- Laura Munoa
- Pablo Mugüerza
- Álvaro Villegas

At the time of writing (January 2023), the dictionary contains 1400 entries from GEC, which have been reviewed, corrected, improved and extended, as well as 6667 new entries from clinical research and related fields (e.g., biostatistics; molecular biology and genetic engineering; drug discovery and development; genome editing; epidemiology; pharmacovigilance; metrology or pharmaceutical registration).

The entries in this dictionary essentially consist of a headword in English and one or more Spanish equivalents. My choice of Spanish terms was guided by their frequency of use, but I have highlighted words that are somewhat controversial because they are either linguistically or conceptually incorrect, or simply ambiguous.

Many of the main entries include fields with additional information that I will briefly explain below using some examples from the dictionary.

For English expressions with numerous possible translations in Spanish, I provide the most common —or the most suitable— translation and then list other possibilities in the sections Otras variantes o posibilidades (Other variants and possibilities) and En otros contextos (Other contexts), i.e., contexts outside clinical research. Example:

Translations that might be considered controversial because of linguistic incorrectness, conceptual inaccuracy or ambiguity are denoted by a warning asterisk (*), regardless of their frequency of use:

Words and expressions with a clearly local flavour are denoted by a superscript two-character code indicating the country or geographic region: ^AM for Latin America, ^AR for Argentina, ^ES for Spain and ^MX for Mexico:

The section Sinónimos (Synonyms) provides common equivalents in English (including British and American English variants), while the section Abr. includes all types of shortened forms (e.g., initialisms, acronyms, contractions and symbols) that are common in written English. These may be included as an abbreviated form of a headword or of any of its synonyms:

Many of the entries contain three sections that will be of particular interest to translators: Contexto (EN) (English context), Contexto (ES) (Spanish context) and Notas (Notes).

a) Contexto (EN): The English context section includes definitions or examples of usage in English together with the source reference in square brackets.

b) Contexto (ES): The Spanish context section includes definitions or examples of usage in Spanish together with the source reference in square brackets.

c) Notas: The Notes section offers additional information of interest to translators, such as warnings regarding usage, learning points and references to original sources.

As all the English synonyms and abbreviations that appear in the main entries also have an entry of their own, this dictionary has, at the time of writing (January 2023) over 8000 entries, as well as 6000 cross references, both increasing the usefulness of the dictionary and making it much simpler to browse.

In the second case, the example shows that ARI is an abbreviation for both absolute risk increase and annual risk of infection (among other possibilities), and that the Spanish equivalent will be found within their respective entries.

The dictionary also uses another type of cross referencing, denoted by an arrow (→), which directs the user to another part of the dictionary to clarify doubts, learn more, or compare the term with another one with an opposite or complementary meaning:

Some of these terms, while not strictly synonyms, are very closely related and as such are sometimes used interchangeably.

Finally, there are plans to add diagrams and figures to some of the entries. At the time of writing (January 2023), these illustrations are being typeset, but, as the definitive versions are not yet available, I have decided not to include them.

b. Secondary entries

Secondary entries refer users to a main entry. When the secondary term is a true synonym of the main term, the entry consists of the headword, numbered meaning(s) in English and a cross reference to the main entry or entries. These entries may include notes. Example:

When the secondary term is not a true synonym, the entry consists of the headword, its equivalent in Spanish, and a cross reference to the main entry. These entries may include notes. Example:

When an abbreviation stems from one or more main entries, cross references are provided to direct users to the expanded terms. Examples:

When the abbreviation, however, is a synonym of a main entry, the English equivalent is given and the user is directed to the corresponding headword. Example:

The dictionary’s search engine has three horizontal boxes. The box on the left contains a drop-down menu for choosing one of the five search modes (Entry, English term, Entry contains, Entire dictionary and Spanish term). The box in the middle is a free text box for inserting the search term, and the box on the right is the search button.

It uses different algorithms depending on whether the user wants to search for:

a) Entry is the preselected mode, whereby users can search both single terms (e.g., target) and multi-word headwords (e.g., clinical trial) in English. There is no need to type multi-word headwords in between double inverted comas (“ ”), since, as soon as the user types the first two letters of the headword, the search bar displays a drop-down menu containing the first ten entries beginning with the exact sequence of letters typed. When the searched headword appears on the drop-down list, the user can just click on it, instead of typing the entire headword.

b) Searching for target while selecting the mode Entry contains will yield not only the single-word entry target, but also any other multiple-word entries containing target as part of the headword (e.g., target assessment, drug target or quality target product profile).

c) English term will find not only entries that contain target as part of the headword —as Entry contains does— but it will also extend the search to the fields Sinónimos [Synonyms] and Contexto [Context], so it will yield, for instance, those entries that contain target as part of a contextual phrase, such as the protein may have potential as an actionable target, which can be found within the entry actionable.

d) Entire dictionary allows users to search for terms contained in any of the fields of an entry (i.e., Sinónimos [Synonyms], Contexto [Context], Notas [Notes] y Remisiones [Cross references]).

e) This resource is not designed to be used as a Spanish-into-English dictionary. However, the Spanish term mode allows users to search for Spanish equivalents of English terms in any part of the dictionary. A search for indicación, for example, will return not only the entries indication (indicación [meaning no. 1]) and labeling (indicación autorizada [meaning no. 4]), but also entries such as claim, which contains the expression claimed indication (indicación pretendida or indicación solicitada) within the Context field; and investigational medicinal product, which contains the Spanish translation of a contextual sentence that includes the term indication (cuando se utilicen para tratar una indicación no aprobada o para obtener […]).

Any endeavour that strives for perfection is reliant on contributions from colleagues who help to pave this road towards excellence, and this dictionary is no exception.

The following experts in medical translation (listed in alphabetical order) all made significant contributions to this dictionary by providing terms, proposed translations, examples, suggestions, comments and references, not to mention large doses of enthusiasm, humour and patience:

• Álvaro Villegas (Alto Alentejo, Portugal). Álvaro is a pharmacist with direct experience in the clinical trial industry and over 20 years’ experience as a translator for the pharmaceutical industry.
• Fernando A. Navarro (Cabrerizos [Salamanca], Spain). Fernando is a doctor specialised in clinical pharmacology with over 30 years’ experience as a translator for the pharmaceutical industry. He is also a trainer, a conference speaker, and an author of countless articles and two extraordinary bilingual medical dictionaries: el Libro rojo and Medizin.
• Laura Munoa (Madrid, Spain). Laura has a degree in medicine and surgery and over 30 years’ experience as a translator in the medical, pharmaceutical and public health fields.
• Lorenzo Gallego (Barcelona, Spain). Lorenzo has a degree in translation and is a sworn translator and a lecturer in scientific translation at the Universidad Autónoma de Barcelona. He has over 14 years’ experience.

I would also like to thank Pablo Mugüerza, a doctor and translator specialised in clinical trial protocols and co-author of GEC (Clinical Trials Glossary). His publications, which are cited in the bibliography for DIC, helped improve several of the dictionary’s headwords.

I would also like to reiterate my thanks to another key GEC contributor, José A. Tapia Granados (economist and doctor specialised in public health, Michigan, USA), for shedding light on particularly complicated statistical and epidemiological terms. Thanks to his explanations, the notes I included in GEC are still valid and also now form part of this dictionary.

I would also like to thank the members of the Tremédica and MedTrad translation forums. Many of the terms in the Clinical Trials Glossary and this dictionary were inspired by the countless exchanges that have taken place in these forums over the years. I would like to give special mention to the following people (again, listed in alphabetical order) for their contributions to the many discussions held: Alfonso Nevado, Ana Atienza, Ana Weyland, Bertha M. Gutiérrez Rodilla, Blanca Mayor Serrano, Cristina Márquez Arroyo, Gustavo Silva, Ignacio Navascués, José Bocic, José María Izquierdo, Luis Pestana, María José Hernández Weigand and María Luisa Clark.

Last but not least, I would like to thank all the members of the Cosnautas team for giving me the opportunity to publish this dictionary on their online platform. In particular, I am extremely grateful to:

• José Antonio de la Riva Fort (editor and university lecturer, Lima, Peru) for his professionalism and exquisite savoir-faire, his endless patience and his timely prompts and advice that made it possible to publish DIC on schedule;
• Laura Munoa, for her unconditional help throughout the creation of this dictionary, in particular for reading draft versions with an eagle eye, for revising the translations from French, for compiling the bibliography and for dealing with the proverbial Spanish red tape; and
• Fernando Navarro, for his unending enthusiasm, generosity, wisdom, willingness to help with terminology queries, and advice and tips on how to use the TLex dictionary compilation suite.

Without the altruism, enthusiasm and experience of all these people, this dictionary would not have been possible.

María Verónica Saladrigas has a PhD in Biological Sciences (with a specialisation in molecular biology) from the Faculty of Exact and Natural Sciences (FCEyN) at the University of Buenos Aires, Argentina. She studied for her doctoral project in Argentina and Switzerland and completed her dissertation in 1993. María Verónica worked as a technical translator (EN and FR>SP) for several United Nations agencies from 1994 to 1996, before moving to Drug Registration Affairs at Novartis in Basel, Switzerland in 1997, where she has held positions of increasing seniority as a translator and revisor. She has been group head since 2015, and currently manages an in-house team of over 40 translators. She has authored and co-authored several online glossaries and term banks published in the award-winning medical and translation journal Panace@, which she co-founded in September 2000.